Page 1

cullinan ONCOLOGY Cullinan Oncology Announces Updated Phase 1 / 2a Data for CLN - 081 in NSCLC EGFR Exon 20 Patients December 16 , 2021 CLN - 081 continues to demonstrate a differentiated clinical profile at the recommended Phase 2 dose of 100mg BID Continued high response rate with favorable safety and tolerability profile observed in heavily pre - treated patients at 100mg BID Encouraging durable responses and progression free survival at 100mg BID CAMBRIDGE , Mass . , Dec. 16 , 2021 ( GLOBE NEWSWIRE ) -- Cullinan Oncology , Inc. ( Nasdaq : CGEM ) ( " Cullinan " ) , a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for cancer patients , today reported updated data from the Company's ongoing Phase 1 / 2a trial of CLN - 081 in non - small cell lung cancer ( NSCLC ) patients whose tumors harbor epidermal growth factor receptor ( EGFR ) exon 20 insertion mutations that have progressed on or after prior therapy . " The updated data from our ongoing Phase 1 / 2a study in a larger number of patients further reinforce CLN - 081's differentiated clinical profile . CLN - 081 has demonstrated both a high response rate and durable responses in heavily pre - treated patients , " said Nadim Ahmed , Chief Executive Officer of Cullinan Oncology . " For many lung cancer patients currently receiving EGFR inhibitors , treatment related side effects can significantly impact their daily lives . In this regard , we are encouraged by CLN - 081's favorable safety profile at the 100mg BID dose . " The current analysis of the ongoing trial included a total of 73 NSCLC patients with EGFR exon 20 insertion mutations who received at least one dose of CLN - 081 and were evaluable for safety as of the data cutoff . CLN - 081 was administered orally , at dose levels including 30 , 45 , 65 , 100 and 150 mg twice daily ( BID ) . Based on prespecified safety and efficacy criteria , enrollment at the Phase 2a cohort for 100mg BID was expanded up to the planned maximum of 36 patients . Additional patients were also enrolled at the 150mg BID dose level , although enrollment was subsequently discontinued after a total of 11 patients based on overall assessment of the clinical profile at this dose level . Guided by these data , 100mg BID was nominated as the Recommended Phase 2 Dose ( RP2D ) for CLN - 081 . Efficacy Highlights : Efficacy data from patients enrolled in the 100mg BID cohort : • Of 36 response evaluable patients , 14 achieved a confirmed PR for a 39 % confirmed response rate and one additional patient had a PR that was pending confirmation at the time of the data cut - off . • The median duration of response was > 15 months and the median progression free survival was 12 months in the initial cohort of phase 1 patients ( N = 13 ) . Safety and Tolerability Highlights : Treatment related EGFR associated adverse event ( AE ) data for patients enrolled in the 100mg BID cohort : • Rash has been limited to Grade 1 and 2 events ( 54 % and 18 % of patients , respectively ) . Events were manageable with conventional supportive care and no patients have experienced Grade 3 or greater treatment - related rash . • Diarrhea has been limited to Grade 1 and 2 events ( 26 % and 8 % of patients , respectively ) . No prophylactic regimen has been required to ameliorate the incidence or severity of diarrhea to date , and no patients have experienced Grade 3 or greater treatment - related diarrhea . " We are pleased with CLN - 081's safety and efficacy to date . CLN - 081 has demonstrated antitumor activity among heavily pre - treated patients , including patients treated previously with other EGFR inhibitors or immunotherapy , and across a spectrum of exon 20 mutational sub - types , " said Jon Wigginton , M.D. , Chairman of the Cullinan Oncology Scientific Advisory Board and Senior Advisor . " We are similarly encouraged by the emerging durability data shown in this update , which we believe could also reflect the benefit of the drug's favorable safety and tolerability profile . Our goal now is to review these results and potential future clinical development with the FDA and to move CLN - 081 as expeditiously as possible into late - stage development . " Additional data are available in a presentation accompanying this press release on the Events section of our website . About CLN - 081 CLN - 081 is an orally available , irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR . Cullinan is evaluating various doses of CLN - 081 in a Phase 1 / 2a trial in patients with NSCLC harboring exon 20 mutations whose disease has progressed on or after prior therapy . About Cullinan Oncology Cullinan Oncology is a biopharmaceutical company that is developing a diversified pipeline of targeted therapeutic candidates across multiple modalities in order to bring important medicines to cancer patients . The Company's strategy is to source innovation through both internal discovery efforts and external collaborations , focusing on advanced stage assets with novel technology platforms and differentiated mechanisms . Learn more